Walmart Health To Acquire Telehealth Provider MeMD

 Acquisition will enable Walmart Health to continue focus on seamless experience and improved health

Walmart Health and MeMD, a multi-specialty telehealth provider, today announced they have entered into an agreement for Walmart Health to acquire MeMD. This reinforces Walmart’s commitment to integrated, omnichannel health delivery that leverages data and technology to improve engagement, health equity and outcomes.

This acquisition will, over the coming months, allow Walmart Health to provide access to virtual care across the nation including urgent, behavioral and primary care, complementing our in-person Walmart Health centers. Our focus on consumer engagement, improved health outcomes and early, equitable access remains the cornerstone of quality health care that can help lower overall health care costs across all populations.

“Telehealth offers a great opportunity to expand access and reach consumers where they are and complements our brick-and-mortar Walmart Health locations. Today people expect omnichannel access to care, and adding telehealth to our Walmart Health care strategies allows us to provide in-person and digital care across our multiple assets and solutions,” said Dr. Cheryl Pegus, executive vice president, Health & Wellness. “Our Health & Wellness mission is to focus on the consumer’s seamless experience and improved health. We are excited to welcome MeMD employees to the Walmart family, and we are looking forward to together, accelerating health care access across the country.”

MeMD was founded in 2010 by Dr. John Shufeldt to provide virtual care nationwide, leveraging the latest online technologies to deliver high-quality care 24/7/365 in a convenient and accessible manner. Today, MeMD delivers medical and mental health visits to millions of members nationwide.

“We’ve achieved incredible strides in making health care available to individuals and businesses around the country through our easy, affordable and intuitive online platform. We can’t imagine a better partner than Walmart as we are both committed to innovative health care delivery and bringing affordable, high-quality care to as many people as possible,” said MeMD chief executive officer Bill Goodwin. “MeMD’s mission fits perfectly with Walmart’s dedicated focus to help people save money and live better, and now we can impact millions more by being part of Walmart.”

The acquisition, which is subject to regulatory approval, is expected to close in the coming months.

https://corporate.walmart.com/newsroom/2021/05/06/walmart-health-to-acquire-telehealth-provider-memd

Panel splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug

 The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The tie vote on whether the FDA should approve the drug was preceded by a vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Contentious debate over whether the one, relatively small Phase III trial comparing avacopan with prednisone was robust enough for a full approval. FDA raised concerns about the statistical analyses of the data in the trial and what effect the use of glucocorticoids on top of cyclophosphamide or rituximab in both treatment arms had on the avacopan efficacy. ChemoCentryx defended its trial design and explained how it met its primary endpoint and showed a reduction in the use of steroids with avacopan.

Those voting against approval raised concerns about relying on the single trial as evidence, the insufficient amount of safety data, and questions on whether the trial was statistically robust enough. Some panelists called for ChemoCentryx to run another trial.

AAC panelist John Sperati, associate professor of medicine at Johns Hopkins University School of Medicine, voted no on whether the FDA should approve the drug and said he had concerns with the study design and persuasiveness of the data. He explained how if avacopan is approved by the FDA, one would have to use it in a similar fashion as in the trial, but where its true efficacy lies remains unclear from that trial data.

Another panelist Julia Lewis, professor of medicine at Vanderbilt University Medical Center, also voted against approval and said the indication is too broad and far exceeds the data presented.

Those voting in favor of approval noted that the trial just cleared the bar to meet its primary endpoint and that trials in this population are difficult to conduct.

AAC panelist Walter Kraft, professor of medicine and surgery at Sidney Kimmel Medical College of Thomas Jefferson University, voted for avacopan to be approved, saying regulatory decisions are not made in a vacuum, but with existing therapeutics in mind, and that the trial met its goal. He also raised concerns about delays in access to avacopan if the FDA requires an additional trial.

Fellow panelist Margrit Wiesendanger, associate professor at Icahn School of Medicine at Mount Sinai, also voted in favor of approving the drug, but said judicious use of it will be warranted and additional guidance will be necessary to explain who exactly should receive it.

Those voting in favor of approval followed a series of concerns raised by FDA statistical reviewer Yura Kim on the company’s assessments of the data, noting, “Statistical analyses of the primary endpoint using the Investigator assessment of BVAS [a clinical scoring system of disease activity to identify active vasculitis in nine organ systems] remission resulted in smaller magnitude of treatment effect and would not support superiority of avacopan.”

The agency also questioned if the other drugs used in the study may have contributed to the efficacy seen for avacopan.

“In this case, both treatment arms received background therapy in the form of cyclophosphamide or rituximab. The benefit of glucocorticoids on top of cyclophosphamide or rituximab is not well understood,” Kim said. “As a result, it is difficult to determine if similar remission rates observed on both arms can support a conclusion that avacopan is effective or if similarities can be primarily attributed to both arms receiving rituximab or cyclophosphamide.”

The company defended its study design, noting that when rituximab won approval in this indication, it was primarily based on results from a single trial of about 200 patients, and was designed as a non-inferiority, comparator trial over 26 weeks.

Following that lead, ChemoCentryx in July 2016 initially proposed a 26-week randomized, double-blind trial comparing avacopan to prednisone in 232 patients receiving either rituximab or cyclophosphamide, Pirow Bekker, the clinical lead for the avacopan clinical development program, explained.

The European Medicines Agency agreed to the non-inferiority study, according to Bekker, with the demonstration of superiority in a secondary endpoint, such as glucocorticoid toxicity.

But in the US, FDA said a 26-week non-inferiority study was not sufficient, he noted. In order to address both FDA and EMA’s feedback, ChemoCentryx revised the study to be a 52-week study in about 300 patients, with the superiority assessment built in as well.

FDA’s Rachel Glaser confirmed that there was an expectation agreed to in the pre-submission discussions that superiority would need to be confirmed for avacopan and that non-inferiority would not be enough.

The FDA is not required to follow the advice of its advisory committee on ChemoCentryx’s avacopan, but in general, the agency usually does.

https://endpts.com/adcomm-splits-slightly-in-favor-of-fda-approving-chemocentryxs-rare-disease-drug/

Corcept suspends Phase 2 NASH study

 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced interim findings from the Phase 2 trial of its selective cortisol modulator miricorilant in patients with presumed NASH.

“This was our first trial to evaluate miricorilant as a treatment for patients with liver disease. When we observed elevated ALT and AST levels in four of the first five patients who received miricorilant for four weeks, we suspended the study,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Our investigation has made two notable findings. First, the elevations in ALT and AST resolved after miricorilant was withdrawn.”

“Second, the patients with elevated liver enzymes exhibited large reductions in liver fat rapidly.” (See Table 1)

Patient	Miricorilant (per day)	Days on Drug	% Liver Fat at Baseline	% Liver Fat at Follow up	Days Between Last Dose and Follow-up	Relative Reduction in % Liver Fat
Patient 1	900 mg	30	17.6	6.1	19	-65.3	%
Patient 2	900 mg	31	27.8	17.1	64	-38.5	%
Patient 3	900 mg	44	28.3	15.0	16	-47.0	%
Patient 4	600 mg	34	12.6	3.3	21	-73.8	%
Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

“We had planned to enroll 120 patients in this study, which we thought would be sufficient to detect a 30 percent reduction in liver fat after 12 weeks,” continued Dr. Grauer. “These patients exhibited much larger reductions after receiving miricorilant for 4-6 weeks. These findings are particularly striking because their follow-up liver MRI was some distance from their final dose.”

“Liver fat reductions achieved this quickly and of this magnitude are rarely seen ,” said Dr. Stephen A. Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University and principal investigator in Corcept’s Phase 2 trial. “Fatty liver disease and NASH afflict many millions of people and there are no approved treatments. Further study is warranted to evaluate if miricorilant can produce such significant reductions in liver fat safely and that the reduction results in a meaningful improvement in NASH.”

https://finance.yahoo.com/news/corcept-therapeutics-observes-large-reductions-200500654.html

Biden willing to accept 25% corporate tax rate to fund spending

 U.S. President Joe Biden said a corporate tax rate between 25% and 28% could help pay for badly needed infrastructure, suggesting he could accept a lower rate than what he has proposed in his search for Republican support for the funding.

"The way I can pay for this, is making sure that the largest companies don't pay zero, and reducing the (2017 corporate) tax cut to between 25 and 28" percent, Biden said during a visit to Lake Charles, Louisiana.

In his $2.3 trillion infrastructure plan, the Democratic president initially proposed raising the corporate tax rate from 21% to 28%. Tax experts and congressional aides told Reuters in April that a 25% rate would be a likely compromise.

"What I'm proposing is badly needed" and will be paid for, Biden said.

"Trickle-down ain't working very well," he said, referring to the theory that helping businesses and the wealthy will benefit those further down the economic ladder. "We've got to build from the bottom up and the middle out."

The U.S. corporate tax rate dropped to 21% from 35% after the 2017 tax cut pushed by then-President Donald Trump and his fellow Republicans, but many big U.S. companies pay much less.

Increasing what companies pay into the more than $4 trillion federal budget is an important part of Biden’s plan to restructure the U.S. economy to reduce inequality and to try to counter China’s rise.

Biden's stop in Lake Charles was part of his "Getting America Back on Track Tour" to promote a $2.25 trillion infrastructure spending plan and a $1.8 billion education and childcare proposal.

https://news.yahoo.com/biden-visit-storm-battered-louisiana-101444433.html

Why BioCryst Is Soaring

 Shares of BioCryst Pharmaceuticals (NASDAQ:BCRX) were soaring 14.5% higher as of 10:51 a.m. EDT on Thursday. The big gain came after the drugmaker provided its first-quarter update before the market opened.

BioCryst had plenty of good news to share in its quarterly update. The company reported total revenue in Q1 of $19.1 million, more than doubling the consensus Wall Street revenue estimate of $8.9 million.

The primary driver of this strong growth was Orladeyo. The hereditary angioedema (HAE) drug generated net sales of $10.9 million in Q1, its first full quarter on the U.S. market. BioCryst stated that the majority of these sales came from new patients who switched to Orladeyo from other medications or from acute-only treatment.

In addition to its better-than-expected sales, BioCryst also announced that it's reached an agreement with the U.S. Food and Drug Administration (FDA) to use change from baseline in hemoglobin as the primary endpoint for its planned pivotal clinical studies evaluating BCX9930 in treating rare disease paroxysmal nocturnal hemoglobinuria (PNH). The company reported clinical results in March that showed the experimental drug achieved significant increases of hemoglobin in PNH patients.

The biotech stock could have several potential catalysts on the way. BioCryst received European Commission approval for Orladeyo on April 30. The company plans a commercial launch of the drug in Germany this quarter and will follow up by launching Orladeyo in other European markets. It also hopes to win U.K. approval of the drug.

https://www.fool.com/investing/2021/05/06/why-biocryst-pharmaceuticals-stock-is-soaring-toda/

Switzerland says U.S. announcement on vaccine patent waiver leaves questions

 The Swiss government said on Thursday a U.S. announcement to support waiving intellectual property rights for COVID-19 vaccines was a significant announcement but left many questions unanswered.

"This is an important announcement by the U.S., but many questions remain unanswered about the specific solutions it is considering in this context," the State Secretariat for Economic Affairs (SECO) said in an emailed statement.

SECO said Switzerland was still convinced that waiving intellectual property rights in the context of the pandemic could not guarantee fair, affordable and rapid access to vaccines, drugs and diagnostic products against COVID-19.

It said Switzerland would examine this new U.S. request and its consequences on the Swiss position, with the United States itself and within the World Trade Organisation.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Switzerland-says-U-S-announcement-on-vaccine-patent-waiver-leaves-questions-33183173/

U.S. Schools Turn Focus to Mental Health of Students Post Pandemic

 As COVID-19 upended education during the past year, Pennsylvania middle school teacher Jennifer Lundberg often began her English lessons gauging the mental wellbeing of her students.

Sometimes, she would turn the lights off and dedicate a few minutes of in-person class to walking the kids through exercises that asked them to identify stressors they were experiencing.

With her own teenage daughter suffering from bouts of depression and anxiety brought on by the pandemic, the veteran teacher saw evidence all around her of the urgent need for mental health support for young people.

"They are struggling in a way that I feel like a lot of times they don't even have words for," Lundberg said. "I've had students who have left in the middle of the day to go to the ER to get evaluated."

Lundberg teaches in the Parkland School District in Allentown, where school officials said the coronavirus has been a catalyst for getting better mental health training for staff and care for its more than 9,000 students.

Educators across the country agreed students' mental wellbeing became a bigger priority after the pandemic forced schools to shut down or operate with a mix of remote and in-person learning. Some students struggled to focus, and isolation, worry and depression took a toll on many.

A Reuters survey earlier this year of U.S. school districts serving more than 2.2 million students found that a majority reported multiple indicators of increased mental health stresses among students.

Those concerns have led to a flood of new funding and initiatives aimed at helping schools navigate the pandemic's aftermath.

The federal COVID-19 relief package included $122 billion for K-12 schools to implement "strategies to meet the social, emotional, mental health and academic needs" of the hardest-hit students. President Joe Biden's budget proposal released in April includes another $1 billion to add nurses and mental health services in public schools.

In Utah, a bill signed in March makes mental health a valid excuse for a school absence. Similar legislation has been introduced in other states including Connecticut and Maryland.

Next month, the National Center for School Mental Health will launch ClassroomWISE. The free online course will train U.S. teachers and school staff on how to create a safe and supporting classroom environment, and how to support students with mental health concerns.

Districts nationwide have said the pandemic "has kind of given them a vitamin D shot" in terms of awareness and resources, said Sharon Hoover, co-director of the government-funded center. Sustained focus will be needed for success, she added.

"We'd be kind of kidding ourselves if we think everyone's going to walk into school doors and things go back to normal," Hoover said.

FRESH MOMENTUM

Many districts still lack sufficient resources and training, however. And experts say even where there are protocols and initiatives already in place, the severity and novelty of some circumstances amid the pandemic pose challenges.

Amy Molloy, the director of school mental health resources at the non-profit Mental Health Association in New York State, said she thought the state's schools were well-positioned to attend to students' mental health thanks to legislation passed in recent years before COVID-19 hit.

But the toll of the pandemic is hard to predict.

"There's a lot of concern and uncertainty about what kind of trauma experiences, what kind of grief and loss, what kind of enhanced mental health problems... are students bringing back," Molloy said.

Before the coronavirus, insurance roadblocks had hampered the Parkland School District's efforts to provide students with one-on-one psychotherapy sessions for their mental health needs, said Brenda DeRenzo, the director of student services.

The pressure created by COVID-19 allowed the Pennsylvania district to finally overcome the financial hurdles through a partnership last fall with a local hospital that linked its middle and high school students with licensed clinicians.

This fall, when students return to full-time in-person learning, the district will implement programs to help them readjust to school and reconnect with their peers.

One initiative will link students to community outreach programs such as a food drive or a nursing home in an effort to rebuild the camaraderie lost to the pandemic, DeRenzo said.

Lundberg, who teaches at Orefield Middle School, said she plans to start hosting morning meetings with parents to facilitate more communication about how their children are coping.

"These kids are good kids, they're just done; they're burned out," she said.

https://news.yahoo.com/u-schools-turn-focus-mental-100713887.html